EMBLETTA MPR


Device Classification Name

ventilatory effort recorder

510(k) Number K122516
Device Name EMBLETTA MPR
Applicant
EMBLA SYSTEMS
1 hines rd ste 202
kanata, 

CA

k2k 3c7

Applicant Contact jennifer armstrong
Correspondent
EMBLA SYSTEMS
1 hines rd ste 202
kanata, 

CA

k2k 3c7

Correspodent Contact jennifer armstrong
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 08/17/2012
Decision Date 02/21/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No